Biologic Can Lessen Steroid Exposure

SAN FRANCISCO—Steroid withdrawal under two-dose daclizumab induction on day two following renal transplantation provides excellent one-year patient and graft survival, researchers reported here at the 2007 World Transplant Congress.

Doctors at Lankenau Hospital in Wynnewood, Pa., retrospectively studied 108 consecutive patients who un-derwent their first kidney transplant and received tacrolimus and mycophenolate mofetil as maintenance immunosuppression.

The first 55 patients (group S) received induction therapy with either thymoglobulin (deceased donor) or daclizumab (living donor) and long-term steroids. The next 53 patients (group NS) received daclizumab on day 0 and day 14, and steroids on day 0 and day 1 only.

Eight allografts were lost in the first week, four in each group. Four allografts were lost because of primary non-function (PNF); thrombosis, hyperacute rejection, rupture, and patient death each caused the lost of one allograft. All instances of PNF occurred in allografts harvested from donors following cardiac death.

The remaining 100 patients (51 in group S and 49 in group NS) were analyzed further for patient and graft survival outcomes. The two groups were similar with respect to mean age and gender and racial mix, donor type, and quality of the deceased donor kidney. The mean length of follow-up was 45 months for group S versus 20 months for group NS.

Patient survival rates at one-year were 96% for both groups, according to lead investigator Francisco Badosa, MD, director of the Kidney Transplant Program at Lankenau. Graft survival rates at one year were 96% for group S and 94% for group NS. Delayed graft function occurred in 31% of group S and 41% of group NS. Acute cellular rejection occurred in 2% and 10%, respectively. None of the differences between the groups were statistically significant, the study found.

Dr. Badosa and his colleagues concluded that patients who do not receive long-term steroids can still have good results. “So, there is good news here,” Dr. Badosa said. “There can be a cost savings, and it is not so much because of the cost of the medications but because you avoid some of the side effects of the corticosteroids, such as diabetes, hypertension, weight gain, and bone disease. So in the long run you may be saving money and improving quality of life.”

In group NS, the incidence of acute cellular rejection was similar for African Americans and non-African Americans (7% and 12%) and in recipients of live donor versus deceased donor organs (10% and 11%, respectively). All long-term graft losses except one were due to death with a functioning kidney.

“In most centers where the programs are doing steroid avoidance they consider African Americans to be at high risk, and they might not consider them for these types of protocols,” Dr. Badosa said. “We decided to recruit them and, even so, our incidence of rejection in African Americans was slightly lower than in non-African Americans. So, I think it is a good protocol for these patients, too.”

He said the study also suggests that the aggressive use of organs from donors who died from cardiac causes (30%) and extended criteria donors (21%) has resulted in a higher incidence of primary non-function and delayed graft function, Dr. Badosa's team reports.